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Prostate AdenocarcinomaNCT05735223

A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy on the Stretched Flaccid Penile Length and Continence

A study testing Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP). in people with Prostate Adenocarcinoma and Incontinence Stress, run by Larkin Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

After robotic prostatectomy, besides erectile function and achievement of oncological control, staying dry is also a very important desire expressed frequently by the patients. This has led to the concept of trifecta achievement after robotic prostatectomies. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
30 Sep 2021to 15 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Exposure to androgen deprivation therapy
  • Prior treatment for prostate cancer
  • Metastatic prostate cancer
  • History of hypospadias or urethral reconstruction
  • History of penile implant, intracorporal injections, intraurethral suppositories
  • Prior pelvic surgery. -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Larkin Health System

    Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy in Terms of Continence Rates

After robotic prostatectomy, besides erectile function and achievement of oncological control, staying dry is also a very important desire expressed frequently by the patients. This has led to the concept of trifecta achievement after robotic prostatectomies. Hence, continence preserving prostatectomies are the order of the day today. Patient acceptance to surgery is low if the continence cannot be assured preoperatively. Many techniques have been promulgated in the last two decades.

The investigators present a novel technique of maximal urethral length preservation during surgery as an effective method of continence preservation. The investigators hypothesize that maximal preservation of urethra would lead to improved and early continence after robotic prostatectomy. The investigators also hypothesize that urethral preservation spares penile length shortening. The investigators therefore propose to prospectively evaluate penile length shortening.

While penile length change after radical prostatectomy has been studied in the past, the investigators like to assess the penile morphometric assessment following the novel technique of maximal urethral length preservation radical prostatectomy.

Being tested
Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).
Medical subject headings
Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).Procedure or surgery

    Stretched flaccid penile length (SFPL) was measured by a single male assessor at preoperative visit, and at the time of catheter removal (10 days post-surgery). The subjects were blinded to the measurements to prevent bias. Multiparametric MRI (MP-MRI) of the prostate were reviewed when available for surgical planning. All subjects underwent RALP with MULP using the technique previously published by Hamada et al. Continence defined as requiring no pads was assessed at 3 and 6 months postoperatively.

Study groups in NCT05735223
Study groupRoleWhat they receive
Stretched flaccid penile length (SFPL) following RALP.ExperimentalStretched flaccid penile length (SFPL) was measured by a single male assessor at preoperative visit, and at the time of catheter removal (10 days post-surgery).
Receives: Procedure: Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Penile Length

    Stretched Flaccid Penile Length

    Measured: 10 days post operatively

Secondary outcomes (1)

  1. Urinary continence

    Pads used.

    Measured: 3 months and 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start30 Sep 2021
  3. Primary completion15 Jan 2023
  4. Study completion15 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
In an IRB approved study, we prospectively evaluated the stretched flaccid penile length (SFPL) pre and post robot assisted laparoscopic radical prostatectomy (RALP) in subjects with a diagnosis of prostate cancer. The multiparametric MRI (MP-MRI) was utilized for surgical planning if available preoperatively. Repeated measures t-test, linear regression and 2-way ANOVA analyses were performed.
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05735223
Sponsor's protocol ID
LCH-2-092019
Status last verified
Feb 2023
First submitted
9 Feb 2023
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Frey AU, Sonksen J, Fode M. Neglected side effects after radical prostatectomy: a systematic review. J Sex Med. 2014 Feb;11(2):374-85. doi: 10.1111/jsm.12403. Epub 2013 Nov 25.

    PubMed 24267516

  • Paparel P, Akin O, Sandhu JS, Otero JR, Serio AM, Scardino PT, Hricak H, Guillonneau B. Recovery of urinary continence after radical prostatectomy: association with urethral length and urethral fibrosis measured by preoperative and postoperative endorectal magnetic resonance imaging. Eur Urol. 2009 Mar;55(3):629-37. doi: 10.1016/j.eururo.2008.08.057. Epub 2008 Sep 2.

    PubMed 18801612

  • Kadono Y, Machioka K, Nakashima K, Iijima M, Shigehara K, Nohara T, Narimoto K, Izumi K, Kitagawa Y, Konaka H, Gabata T, Mizokami A. Changes in penile length after radical prostatectomy: investigation of the underlying anatomical mechanism. BJU Int. 2017 Aug;120(2):293-299. doi: 10.1111/bju.13777. Epub 2017 Feb 8.

    PubMed 28181381

  • Hamada A, Razdan S, Etafy MH, Fagin R, Razdan S. Early return of continence in patients undergoing robot-assisted laparoscopic prostatectomy using modified maximal urethral length preservation technique. J Endourol. 2014 Aug;28(8):930-8. doi: 10.1089/end.2013.0794. Epub 2014 Apr 16.

    PubMed 24739066

  • Munding MD, Wessells HB, Dalkin BL. Pilot study of changes in stretched penile length 3 months after radical retropubic prostatectomy. Urology. 2001 Oct;58(4):567-9. doi: 10.1016/s0090-4295(01)01270-5.

    PubMed 11597540

  • Hammerer P, Huland H. [Urodynamic changes after radical prostatectomy]. Urologe A. 1997 Nov;36(6):535-9. doi: 10.1007/s001200050133. German.

    PubMed 9487589

  • Fraiman MC, Lepor H, McCullough AR. Changes in Penile Morphometrics in Men with Erectile Dysfunction after Nerve-Sparing Radical Retropubic Prostatectomy. Mol Urol. 1999;3(2):109-115.

    PubMed 10851312

  • Berookhim BM, Nelson CJ, Kunzel B, Mulhall JP, Narus JB. Prospective analysis of penile length changes after radical prostatectomy. BJU Int. 2014 May;113(5b):E131-6. doi: 10.1111/bju.12443. Epub 2013 Dec 2.

    PubMed 24053766

  • Kwon YS, Farber N, Yu JW, Rhee K, Han C, Ney P, Hong JH, Lee P, Gupta N, Kim WJ, Kim IY. Longitudinal recovery patterns of penile length and the underexplored benefit of long-term phosphodiesterase-5 inhibitor use after radical prostatectomy. BMC Urol. 2018 May 9;18(1):37. doi: 10.1186/s12894-018-0341-8.

    PubMed 29739455

  • Dalkin BL, Christopher BA. Preservation of penile length after radical prostatectomy: early intervention with a vacuum erection device. Int J Impot Res. 2007 Sep-Oct;19(5):501-4. doi: 10.1038/sj.ijir.3901561. Epub 2007 Jul 26.

    PubMed 17657210

  • Vasconcelos JS, Figueiredo RT, Nascimento FL, Damiao R, da Silva EA. The natural history of penile length after radical prostatectomy: a long-term prospective study. Urology. 2012 Dec;80(6):1293-6. doi: 10.1016/j.urology.2012.07.060. Epub 2012 Oct 23.

    PubMed 23102441

  • Kadono Y, Nohara T, Kawaguchi S, Sakamoto J, Makino T, Nakashima K, Iijima M, Shigehara K, Izumi K, Mizokami A. Changes in penile length after radical prostatectomy: effect of neoadjuvant androgen deprivation therapy. Andrology. 2018 Nov;6(6):903-908. doi: 10.1111/andr.12517. Epub 2018 Jul 2.

    PubMed 29968337

  • Briganti A, Fabbri F, Salonia A, Gallina A, Chun FK, Deho F, Zanni G, Suardi N, Karakiewicz PI, Rigatti P, Montorsi F. Preserved postoperative penile size correlates well with maintained erectile function after bilateral nerve-sparing radical retropubic prostatectomy. Eur Urol. 2007 Sep;52(3):702-7. doi: 10.1016/j.eururo.2007.03.050. Epub 2007 Mar 26.

    PubMed 17418936

  • Engel JD, Sutherland DE, Williams SB, Wagner KR. Changes in penile length after robot-assisted laparoscopic radical prostatectomy. J Endourol. 2011 Jan;25(1):65-9. doi: 10.1089/end.2010.0382. Epub 2010 Nov 29.

    PubMed 21114411

  • Brock G, Montorsi F, Costa P, Shah N, Martinez-Jabaloyas JM, Hammerer P, Ludovico GM, Lee JC, Henneges C, Hamidi K, Rossi A, Mulhall J, Buttner H. Effect of Tadalafil Once Daily on Penile Length Loss and Morning Erections in Patients After Bilateral Nerve-sparing Radical Prostatectomy: Results From a Randomized Controlled Trial. Urology. 2015 May;85(5):1090-1096. doi: 10.1016/j.urology.2014.11.058. Epub 2015 Mar 24.

    PubMed 25813656

Questions about this trial

What is this clinical trial studying?

A study testing Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP). in people with Prostate Adenocarcinoma and Incontinence Stress, run by Larkin Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Penile Length (time frame: 10 days post operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05735223, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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